Senior Specialist, Quality & Regulatory Affairs
Danaher · Woerden, Netherlands +4 more
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Role summary
Danaher seeks a Senior Specialist in Quality & Regulatory Affairs for its Netherlands diagnostics operations. The role supports quality and regulatory compliance across European markets, with focus on Economic Operator responsibilities under EU legislation including IVDR and MDR. Candidates require a life-sciences degree, medical device/IVD industry experience, ISO 9001 lead auditor certification, and fluency in English and Dutch.
What they're looking for
- Bachelor's degree in Life Sciences, Regulatory Affairs, Quality, or related field
- Quality and/or Regulatory Affairs experience in Medical Device or IVD industry
- ISO 9001 Lead Auditor certification
- Working knowledge of EU regulatory frameworks, specifically IVDR and/or MDR
- Fluent in English and Dutch, written and verbal
- Valid driver's license with acceptable driving record
What you'll be doing
- Support Quality and Regulatory Affairs activities for Netherlands site and European operations
- Maintain, implement, and improve Quality Management System processes and compliance infrastructure
- Serve as subject matter expert on Economic Operator obligations under IVDR and MDR regulations
- Support Importer and Distributor compliance obligations across European regions
- Develop and maintain sustainable Economic Operator compliance processes regionally
Privacy & handoff
This role links to Danaher's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.